Global Quality, Clinical Trials & Safety (GQ-CT&S) is responsible for the quality governance and auditing of clinical trials and safety. GQ CT&S defines the Clinical Quality Management Systems (QMS) enabling strategies and technologies and coordinates Quality Risk management at the compound and process levels to inform the audit focus and drive implementation of Quality Risk Management. GQ CT&S audits all processes related to clinical research and pharmacovigilance, including investigator site, country, process, vendor and partner audits, to assess compliance with relevant regulations and applicable policies and procedures. It is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements. GQ also offers support as SME during Due Diligence and if areas of serious non-compliance are identified.

Purpose/Objective of the job

The Head of GQ CT&S Quality Governance and Risk Assessments is an essential role to build and maintain the Quality Governance and lead the enterprise Risk Assessments and CAPA related to clinical trials and safety. This role reports to the Head of GQ CT&S and is a key member of the GQ CT&S Leadership team.

Key Responsibilities and Major Duties

Quality Governance

Providing strategic and operational leadership of GQ CT&S Quality Governance and Risk Assessments function responsible to build and maintain the Quality Governance and lead the enterprise Risk Assessment and CAPA team.

Defining QMS-enabling strategies and technology to build a sustainable GCP and GVP Quality Culture, including the coordination and chairing of a Clinical Trials Quality Council, maintenance of a Quality Manual and driving implementation of Quality Risk Management and CAPA principles.

Quality Risk Management

Leveraging core risks informing continuous improvement of processes to support compliance with Good Clinical Practices (GCP) and to inform the audit focus and strategy.

Supporting the Quality Risk Management Process at compound level and interdisciplinary processes that go across disciplines in order to lower the risk profile.

Developing and implementing a culture of continuous improvement, supporting that comprehensive corrective action preventative action plans (CAPA) are developed, root cause analysis is captured, for cross-functional issues that are complex.

Overall

Leading a team of quality professionals, expert in risk management, root-cause analysis and CAPA. Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential.

Training the in-process quality functions on QMS capabilities, such as risk assessments and CAPA.

Partnering with the GCO Global Clinical Compliance and Continuous Improvement function to ensure the successful implementation of a QMS. Assess the performance of the QMS.

Prioritizing and focusing on the avoidance of risk for issues that matter.

Acting as a credible, influential and respected spokesperson on matters pertaining to QMS, risk assessments and CAPA both within and outside of the BMS organization.

Watching,actingtrendsinnewandfortoasneeded.

Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively communicates his/her views to senior management.

Collaborating with the Global CTS Leadership to achieve the optimal study, process and vendor audit strategy , in accordance with company objectives, and in consultation with R&D Leadership (clinical, operations, regulatory).

Supporting as SME on QMS during Due Diligence and if areas of serious non-compliance are identified.

Maintains an in-depth knowledge of governmental regulations impacting GCP and development of medicines

Demonstrated expertise and specific technical knowledge of the GCP areas subject to audit, as evidenced by at least 15 years in the pharmaceutical industry or equivalent and 10 years in quality management.

Quality Management and Risk assessment expertise.

Experience supervising others or leading teams.

Understanding of pharmaceutical product development;

Understanding of global regulatory principles related to GCP and their impact on company's development and business;

Understanding of the complexities of cross functional issues;

Innovator and strategic leadership;

Excellent oral and written communication and interpersonal relationship skills with ability to impact and influence people across the matrix;

Sense of diplomacy and discretion;

Maintains the confidentiality and security of information, data, documents and records;

Demonstrates commitment to delivering high-quality work product;

Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective;

Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;